Instructions for use

SonicFill Handpiece

Manufactured for:
Kerr Corporation
1717 W. Collins Ave
Orange CA 92867
U.S.A.

User instructions

1 User instructions
Dear user,
Congratulations on purchasing this Kerr quality product. Following the instructions below will allow
you to work smoothly, economically and safely.

User instructions

Symbols
Refer to the Chapter on Safety/Warning symbols
Important information for users and service technicians

Thermodisinfectable

User instructions

Can be sterilized with steam at 134 C -1 C / +1 C (273 F -1.6 F / +1.6 F)

Action request

Target group
This document is intended for dentists and their assistants. The section on starting up is also
intended for service technicians.

Safety

2 Safety
2.1.1 Description of safety instructions: Warning symbol
Warning symbol

Safety

2.1.2 Description of safety instructions: Structure

DANGER
The introduction describes the type and source of the hazard.
This section describes the potential consequences of non-observance.

The optional step includes necessary measures for hazard prevention.

Safety

2.1.3 Description of safety instructions: Description of danger levels

The safety instructions cited herein with the three levels of danger will help avert property damage
and injury.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild to moderate injuries.

Safety

WARNING
WARNING
indicates a hazardous situation that can cause death or serious injury.
DANGER
DANGER
indicates a hazardous situation that can directly cause death or serious injury.

Safety

2.2 Safety instructions

WARNING
Hazard to the care provider and patient.
Stop working in case of damage, irregular noise during operation, excessive vibration, unusual
build-up of heat or if the SonicFill Unidose tip cannot be firmly held.

Before extended periods of non-use, the instrument must be cleaned, serviced and stored
in dry condition according to the instructions.

Safety

CAUTION
Premature wear and malfunctioning from improper storage during long periods of nonuse.
Reduced product life.

The medical device should be cleaned, serviced and stored in a dry location, according to
instructions, before long periods of nonuse.

Safety

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CAUTION
Injury or damage due to wear.
If you notice uneven operating noises, excessive or unexpectedly low vibrations or the SonicFill
Unidose tip coming undone.

Stop working and contact service support.

Safety

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CAUTION
Swallowing or aspiration of the SonicFill Unidose tip by the patient.

Before each treatment involving the SonicFill handpiece, insert a rubber dam for safety
reasons.

The following persons are authorized to repair and service Kerr products:
Technicians specially trained by Kerr
To ensure proper function, the medical device must be set up according to the methods described
in the Kerr instructions for use, and the care products and methods described therein must be

Safety

12

used. Kerr recommends specifying a service interval at the dental office for a licensed shop to
clean, service and check the functioning of the medical device. This service interval should take
into account the frequency of use.
Service may only be provided by repair shops that have undergone training by Kerr and that use
original Kerr replacement parts.

Product description

13

3 Product description

SonicFill handpiece
SonicFill handpiece is a dental handpiece in accordance with ISO 15606. The handpiece is de
signed for sound-activated dispensation of a composite material that has a greatly reduced vis
cosity during the dispensing process and subsequently quickly transforms into the more viscous
state of a restorative composite.

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3.1 Purpose Proper use

Purpose:
The SonicFill handpiece is a dental delivery system intended to be used to dispense SonicFill, a
dental restorative resin, directly into dental cavities.

Product description

15

This medical device is

intended for dental treatment only. Any other type of use or alteration to the product is im
permissible and can be hazardous.
The SonicFill handpiece must be used exclusively in combination with the SonicFill Unidose
tip for filling dental cavities with composite materials.
A medical device according to relevant national statutory regulations.

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Proper use:
According to these provisions, the medical device is only for the described use in conformance
with:
the applicable health and safety regulations,
the applicable accident prevention regulations
and these instructions for use.

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According to these regulations, the user is required to:

only use properly operating equipment,
use the equipment for the proper purpose,
to protect himself, the patient and third parties from danger,
to avoid contamination from the product.

3.2 Technical Specifications

Drive air

3 4.2 bar (43 61 psi)

Air consumption

20 40 NL/min

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Frequency

5 6 kHz

Ejection force

0 to 170 N

Note that the values above apply to the pressure within the handpiece and not to the dental unit
itself. If the dental unit is set between 2.1 - 3.5 bar (30 - 50 psi) (which is normally the case when
a turbine is used), no adjustment should be necessary. If adjustment is required, please see the
directions for proper measurement and calibration of the handpiece pressure on page 25 of this
manual.
The SonicFill handpiece can be mounted on all MULTIflex couplings.

Product description

19

3.3 Transportation and storage conditions

CAUTION
It is hazardous to start up the medical device after it has been stored refrigerated.
This can cause the medical device to malfunction.

Prior to start-up, very cold products must be heated to a temperature of 20 C to 25 C

(68 F to 77 F).

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Temperature: -20C to +70C (-4F to +158F)

Relative humidity: 5% RH to 95% RH absence of condensation
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture

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4 First use
Mediated by a MULTIflex coupling, the SonicFill handpiece can be connected to any turbine hose
of a treatment unit.
WARNING
Hazard from non-sterile products.
Infection hazard for care provider and patient.

Before first use and after each use, sterilise the medical device.

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4.1 Connection to devices

WARNING
Damage from soiled and moist drive air.
Contaminated and moist drive air can cause malfunctions and lead to premature bearing wear.

Always make sure that the supply of drive air is dry, clean and uncontaminated according
to ISO 7494-2.

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4.2 Installing the MULTIflex coupling

Screw the MULTIflex LUX/MULTIflex LED coupling onto the turbine hose and tighten with
the wrench.

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4.3 Check the O-rings

CAUTION
Missing or damaged O-rings.
Malfunctions and premature failure.

Make sure that all O-rings are on the coupling and undamaged.

Number of available O-rings: 5

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4.4 Check the pressure using a test manometer

A minimum drive pressure of 3 bar (43 psi) measured at the handpiece is required to operate the
SonicFill handpiece. 3.5 bar (50 psi) is ideal. Between 3.5 - 4.2 bar (51 - 62 psi) the drive air will
be automatically reduced within the SonicFill handpiece. The air consumption is approximately 20
- 40 NI/min. Insert the test manometer between the MULTIflex coupling and the SonicFill hand
piece. Adjust regulating ring on level 5.
Pressure displayed:
Drive air T.R. = 3 - 4.2 bar (43 - 61 psi)
Return air R.L. < 0.4 bar (6 psi)
No water or spray air are needed, though.

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5 Operation
5.1 Attaching the SonicFill handpiece

Place the SonicFill handpiece exactly on the MULTIflex (LUX) / MULTIflex LED coupling
and push it to the rear until it audibly locks.

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If your coupling system is equipped with a light, please wait for at least 5 seconds before
you remove the SonicFill handpiece to prevent damage to the light source.
CAUTION

Ensure that the SonicFill handpiece is firmly seated on the coupling.

The SonicFill handpiece can be a hazard for patient and user if it inadvertently comes undone
on the coupling during the treatment.

Before each treatment, pull on the SonicFill handpiece to check if it is securely seated on
the coupling.

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5.2 Detaching the SonicFill handpiece

Hold the MULTIflex (LUX) / MULTIflex LED coupling tight, and pull the SonicFill handpiece
forward while twisting slightly.

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5.3 Inserting the SonicFill Unidose Tips

DANGER
The SonicFill handpiece must be used in combination with SonicFill Unidose tips exclusively.
Noncompliance may lead to product damage. Ensure that the SonicFill Unidose Tips are firmly
attached to the SonicFill handpiece. Before each treatment, pull on the SonicFill Unidose tip to
see if it is securely attached to the instrument. If the SonicFill Unidose tip is difficult to screw-on,
this is due to a defect and the SonicFill Unidose tip must not be used since it may become de
tached during use. Check if the SonicFill Unidose tips are firmly connected by briefly starting-up
the SonicFill handpiece outside the mouth.

Operation

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Operation

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Push the SonicFill Unidose tips by hand into the corresponding opening of the SonicFill
handpiece using moderate pressure and turn the handpiece in a clockwise direction, screw
ing it into the SonicFill tip.

5.4 Removing the SonicFill Unidose Tips

Unscrew the SonicFill Unidose tips by hand from the SonicFill handpiece through a counter
clockwise rotation.

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5.5 Power setting

Use the regulating ring of the SonicFill handpiece to adjust the dispensed quantity.
Level 1 = low, level 5 = high
Dispensing with a variable foot control positions:
Variable foot controls allow the dispensing rate to be controlled with different foot pedals. In this
case, it is recommended to set the regulating ring on the handpiece to 5.

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6 Preparation methods according to ISO 17664

6.1 Preparations at the site of use
WARNING
Hazard from nonsterile products.
There is a risk of infection from contaminated medical devices.

Take suitable personal protective measures.

Remove all residual cement, composite or blood without delay.

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The medical device must be dry when transporting it to the site of reprocessing.
(do not place in any type of solution).
The medical device should be reprocessed as quickly as possible after the treatment.

6.2 Preparations before cleaning

Remove the SonicFill Unidose tips by hand from the SonicFill handpiece.

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6.3 Cleaning
CAUTION
Malfunctions from cleaning in the ultrasonic unit.
Defects in the product.

Only clean manually or in a thermodisinfector.

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6.3.1 Cleaning: Manual cleaning - external

Accessories required:
- Tap water 30 C 5 C (86 F 10 F)
- Brush, e.g. medium-hard toothbrush
Brush under running tap water using, e.g., a medium-hardness toothbrush.

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6.3.2 Cleaning: Automated external cleaning

Kerr recommends thermodisinfectors in accordance with EN ISO 15883 that are operated with al
kaline cleaning agents at a pH of max. 10 (e.g. Miele G 7781 / G 7881 validation was performed
with the ""VARIO-TD" programme, "neodisher mediclean" cleaning agent, "neodisher Z" neutral
isation agent, and "neodisher mielclear" rinsing agent and extends only to the compatibility of
materials with respect to Kerr products).

For program settings as well as cleansers and disinfectants to be used, please refer to the
Instructions for Use of the thermodisinfector (complying with max. pH value of 10).

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In order to prevent negative effects on the medical device made by Kerr, make sure that the
interior and the exterior of the medical device are dry, and then lubricate immediately with
care agents from the Kerr care system.

6.4 Disinfection
CAUTION
Malfunctioning from using a disinfectant bath or disinfectant containing chlorine.
Defects in the product.

Only disinfect in a thermodisinfector or manually.

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6.4.1 Disinfection: Manual disinfection - external

Kerr recommends the following products based on material compatibility.

CaviCide made by Metrex

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Consumables required:
Cloths for wiping off the medical device.
Spray the disinfectant on a cloth, then thoroughly wipe down the medical device and leave the
disinfectant to soak in according to the instructions from the disinfectant manufacturer.
Note
Follow the instructions for use of the disinfectant.

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6.4.2 Disinfection: Machine disinfection - external and internal

Kerr recommends thermodisinfectors in accordance with EN ISO 15883 that are operated with al
kaline cleaning agents at a pH of max. 10 (e.g. Miele G 7781 / G 7881 validation was performed
with the ""VARIO-TD" programme, "neodisher mediclean" cleaning agent, "neodisher Z" neutral
isation agent, and "neodisher mielclear" rinsing agent and extends only to the compatibility of
materials with respect to Kerr products).

For program settings as well as cleansers and disinfectants to be used, please refer to the
Instructions for Use of the thermodisinfector (complying with max. pH value of 10).

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In order to prevent negative effects on the medical device made by Kerr, make sure that the
interior and the exterior of the medical device are dry, and then lubricate immediately with
care agents from the Kerr care system.

6.5 Drying
Manual Drying

Blow off the outside and inside with compressed air until water drops are no longer visible.

Automatic Drying
The drying procedure is normally part of the disinfection program of the thermodisinfector.

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Note
Please follow the instructions for use of the thermodisinfector (compressed air quality - see the
Warning under "Start-up").

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6.6 Care products and systems - Servicing

CAUTION
Premature wear and malfunctions from improper servicing and care.
Reduced product life.

Perform proper care regularly!

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Note
Kerr guarantees the proper function of Kerr products only if the care products listed by Kerr un
der accessories are used, as these have been tested for proper use on our products.

6.6.1 Care products and systems - Servicing: Servicing involving SonicFill Hand
piece Lubrication Spray
Kerr recommends servicing the product after each use after each automatic cleaning and before
each sterilization.

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Note
If the oil leakage is bothersome, once weekly servicing is sufficient.

Remove the SonicFill Unidose Tips.

Cover the product with the cellulose bag.

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Place the product on the SonicFill MULTIflex coupling, and press the spray button for one
second.

6.7 Packaging
Note
The sterilization bag must be large enough for the instrument so that the bag is not stretched.
Seal each medical device individually in a sterilised item package!

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6.8 Sterilization
Sterilization in a steam sterilizer (autoclave) in accordance with EN 13060/ISO
17665-1
CAUTION
Premature wear and malfunctions from improper servicing and care.
Reduced product life.

Service the medical device before each sterilization cycle.

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CAUTION
Contact corrosion due to moisture.
Damage to product.

Immediately remove the product from the steam steriliser after the sterilisation cycle!

Note
Remove the SonicFill Unidose tip before sterilization. The SonicFill Unidose tips are non-steriliz
able.

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The medical device has a maximum temperature resistance up to 138 (280.4 F).

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(Depending on the available autoclave,) select a suitable procedure from the following sterilisation
processes:
Autoclave with pre-vacuum:

at least 3 minutes at 134 C -1 C / +4 C (273 F -1.6 F / +7.4 F)

Drying time: 20 min.
Autoclave using the gravity method:

at least 10 minutes at 134 C -1 C / +4 C (273 F -1.6 F / +7.4 F) or alternatively

at least 60 minutes at 121 C -1 C / +4 C (250 F -1.6 F / +7.4 F)

Drying time for using one of the gravity methods is 30 minutes.

Use according to the manufacturer's Instructions for Use.

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6.9 Storage
Prepared products must be stored, protected from germs (as far as possible) and dust, in a dry,
dark, cool room.
Note
Comply with the expiry date of the sterilised items.

Tools

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7 Tools
Obtainable from an authorized Kerr distributor.
Material summary
SonicFill Handpiece Lubrication Spray
SonicFill MULTIflex coupling

Mat. no.
35207
35134

Terms and conditions of warranty

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8 Terms and conditions of warranty

Kerrs technical advice, whether verbal or in writing, is designed to assist dentists in using Kerrs
product. The dentist assumes all risk and liability for damages arising out of the improper use of
Kerrs product. In the event of a defect in material or workmanship, Kerrs liability is limited, at
Kerrs option, to replacement of the defective product or part thereof, or reimbursement of the ac
tual cost of the defective product. In order to take advantage of this limited warranty, the defective
product must be returned to Kerr. In no event shall Kerr be liable for any indirect, incidental, or
consequential damages. EXCEPT AS EXPRESSLY PROVIDED ABOVE, THERE ARE NO WAR
RANTIES, BY KERR, EXPRESS OR IMPLIED, INCLUDING WARRANTIES WITH RESPECT TO
DESCRIPTION, QUALITY, OR FITNESS FOR A PARTICULAR PURPOSE.

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